Working as part of a multi-disciplinary team on a major fast track medical technology project in the field of fluid management, you will be responsible for the re-engineering of a portfolio of disposable sterile medical products to demonstrate conformance to the product specification and compliance to the new Medical Device Regulations.
Working with a dynamic R&D team and with external suppliers to re-design and upgrade the products. Leading the identification and execution of appropriate design verification test methodologies and the update of the relevant technical design verification documentation to support new regulatory submissions, based upon the necessary changes in components, manufacturing environments and sterilisation methods identified, the successful candidate will be able to exercise their ability in this challenging yet exciting project.
This demanding role will require a good knowledge of plastic disposable medical devices, an ability to problem solve and lead design and development activities with a minimum of supervision. You will need to have had considerable practical experience in this or a similar field of design and be able to work collaboratively to ensure that overall system performance is achieved. You will also need to follow good engineering practices and give due consideration to design and development procedures.
Applicants should also have the following qualifications, experience and attributes:
A degree or equivalent in an appropriate engineering or scientific discipline
Experience in mechanical design or (Preferable) plastics injection moulding and/or extruded components.
A proven ability to apply engineering principles.
Ability to generate test plans and technical reports to a standard that will pass scrutiny against the BS EN ISO 13485 standard and the FDA’s 21 CFR part:820 regulations.
A genuine passion for engineering and for achieving reliable, high quality, cost effective designs.
(Preferable) Hands-on experience of 3D CAD. (Solidworks preferred)
(Preferable) Knowledge of sterilisation processes and standards.